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In a Phase 1 study, 82% of patients on VIR-5500 achieved at least a 50% reduction in PSA levels—a result analysts praised as competitive in the prostate cancer space.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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A new study in JAMA contradicts a series of statements made by HHS Secretary Robert F. Kennedy Jr. that paint vaccine advisory committees at the CDC and FDA as hopelessly corrupt.
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset.
Adaptive and Genentech first partnered in 2018 to advance T cell receptor-based therapies for cancer.
VantAI will use its machine learning capabilities to identify novel target-effector pairs that Halda can use in designing its bifunctional small-molecule drugs.
While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured investors it has the manufacturing capacity to roll out oral semaglutide without restrictions on supply.
A draft copy of the Make America Healthy Again Commission’s latest report, obtained by Politico, focuses on vaccine-related injuries and expediting access to investigational medicines for children—even though the FDA has recently rejected several of them.
Waltham, Massachusetts–based Skyhawk Therapeutics has been collecting collaborations with larger companies in spades since launching in 2018.
Patients who are prescribed Wegovy or Ozempic can now use GoodRx to access the medications at just $499 a month if they skip insurance. This is not the first time Novo has partnered with a pharmacy to offer the blockbuster drugs.
Inclacumab, which Pfizer obtained in its 2022 acquisition of Global Blood Therapeutics, failed to significantly lower pain episodes in patients with sickle cell disease over the 48-week treatment period.
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.